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Dry EyeNCT05906381

Dry Eye Symptom Mitigation by Oral Intake of Probiotics

A study testing Probiotics in people with Dry Eye, run by Chung Shan Medical University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study investigates whether the oral intake of a probiotics capsule product may relieve dry eye symptoms. Participants will be aged between 20 - 65 years of age, with confirmed diagnosis of dry eye status. Read more about this study

Who is it for?
Ages 20 to 65 years
Conditions the study is for
Dry Eye
What is being tested?
Probiotics
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
88 participants
Where
1 siteTaiwan
Study dates
13 May 2023to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • aged between 20 and 65 years
  • with Schirmer's test results less than 10 mm or Ocular Surface Disease Index more than 25

Who cannot join

  • evident ocular diseases such as cornea disease, cataract, vitreous degeneration, glaucoma, and retinopathy.
  • diabetes
  • hypertension
  • or other chronic diseases or belong to vulnerable groups(pregnancy woman, prisoner, ethical minorities, economic or educationally disadvantaged subjects, disabled individuals such as those at terminal stage of tumorigenesis, blindness, terminal ill individuals)

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Jen-Ai Hospital

    Taichung, 412

Other trials in Taiwan

About this study

Official title: A Clinical Trial of Dry Eye Symptom Mitigation by Oral Intake of Probiotics

This study investigates whether the oral intake of a probiotics capsule product may relieve dry eye symptoms. Participants will be aged between 20 - 65 years of age, with confirmed diagnosis of dry eye status. The participants will be assessed for several parameters and asked to take 1 probiotics capsule per day for 35 days. The parameters will include ocular surface health, tear volume, tear quality, intraocular pressure, tear osmolarity and serum biochemical test. After the 35 days are completed, the participants will be assessed again for the same parameters.

Read the detailed description

This investigation is a randomized, double-blind study. Subjects with confirmed diagnosis of dry eye are randomly assigned to control group or treatment group, and asked to orally intake 1 capsule of either placebo or probiotics per day. All participants will be assessed for parameters, including intraocular pressure, ocular surface health, tear film breakup time (TBUT), tear volume (Schirmer's test), tear osmolarity, ocular surface impression cytology, ocular surface disease index (OSDI) and serum biochemical tests for quantification of hyaluronic acid, sialic acid, glutathione contents.The assessments are conducted at day1 for baseline and after the 35-day oral intake. The parameters are used to compare and evaluate whether the probiotics can relieve dry eye symptoms.

Conditions
Dry Eye
Being tested
Probiotics, Placebo
Keywords
probiotics, dry eye, eye sore, eye strain
Medical subject headings
Dry Eye Syndromes, Asthenopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ProbioticsDietary supplement

    A specific probiotics capsule product, containing Streptococcus thermophilus will be given to participants for oral intake for 35 days.

  • PlaceboDietary supplement

    A specific capsule product, containing microcrystalline cellulose will be given to participants for oral intake for 35 days.

Study groups in NCT05906381
Study groupRoleWhat they receive
Control groupPlacebo comparatorSubjects will take a capsule of containing microcrystalline cellulose per day for 35 days.
Receives: Dietary Supplement: Placebo
Treatment groupExperimentalSubjects will take a capsule of containing Streptococcus thermophilus per day for 35 days.
Receives: Dietary Supplement: Probiotics

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of Schirmer's Test Value from Baseline

    The Schirmer's Test is used to assess tear secretion volume. The amounts of tears are measured in total millimeters after 5 minutes has elapsed. Lower measurement amount is regarded as a parameter of presence of dry eye disease.

    Measured: on baseline and day36

  2. Change of Tear Film Breakup Time from Baseline

    Tear Break-Up Time is a measurement to reflect tear quality and is expressed in seconds. The shorter the Tear Break-Up Time, the poorer the tear film stability and quality. Lower measurement outcome (less than 10 seconds) is regarded as a parameter of presence of dry eye disease.

    Measured: on baseline and day36

  3. Ocular Surface Index Change from Baseline

    Ocular Surface Index is assessed with fluorescein staining to reflect ocular surface damages. The staining scale ranges from 0 to 3, from milder to severe status, where grade 0 shows no staining, and grade 3 shows extensive staining.

    Measured: on baseline and day36

  4. Tear Osmolality Change from Baseline

    Tear osmolality is used as a parameter of dry eye status.

    Measured: on baseline and day36

  5. Serum Biochemical Test

    To determine the effects of oral probiotics intake on the contents of hyaluronic acid, sialic acid, and glutathione in the serum.

    Measured: on baseline and day36

Secondary outcomes (3)

  1. Ocular Surface Impression Cytology Change from Baseline

    To assess the status of conjunctival goblet cells and epithelium.

    Measured: on baseline and day36

  2. Ocular Surface Disease Index Score Change from Baseline

    A questionnaire is used to assess the health status on ocular surface, with higher scores indicating more severe status.

    Measured: on baseline and day36

  3. Intraocular Pressure Change from Baseline

    To determine the effects of intervention on intraocular pressure.

    Measured: on baseline and day36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2023
  2. Study start13 May 2023
  3. Primary completion31 Aug 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05906381
Sponsor's protocol ID
202300014B0
Status last verified
Jun 2023
First submitted
19 May 2023
Last updated
26 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Herrero-Vanrell R, Peral A. [International Dry Eye Workshop (DEWS). Update of the disease]. Arch Soc Esp Oftalmol. 2007 Dec;82(12):733-4. doi: 10.4321/s0365-66912007001200002. No abstract available. Spanish.

    PubMed 18040913

  • Fox RI, Chan R, Michelson JB, Belmont JB, Michelson PE. Beneficial effect of artificial tears made with autologous serum in patients with keratoconjunctivitis sicca. Arthritis Rheum. 1984 Apr;27(4):459-61. doi: 10.1002/art.1780270415. No abstract available.

    PubMed 6712760

  • Wilson WS, Duncan AJ, Jay JL. Effect of benzalkonium chloride on the stability of the precorneal tear film in rabbit and man. Br J Ophthalmol. 1975 Nov;59(11):667-9. doi: 10.1136/bjo.59.11.667.

    PubMed 1203224

  • Brito-Zeron P, Ramos-Casals M; EULAR-SS task force group. Advances in the understanding and treatment of systemic complications in Sjogren's syndrome. Curr Opin Rheumatol. 2014 Sep;26(5):520-7. doi: 10.1097/BOR.0000000000000096.

    PubMed 25050925

  • Sullivan DA, Krenzer KL, Sullivan BD, Tolls DB, Toda I, Dana MR. Does androgen insufficiency cause lacrimal gland inflammation and aqueous tear deficiency? Invest Ophthalmol Vis Sci. 1999 May;40(6):1261-5.

    PubMed 10235562

  • Schrader S, Mircheff AK, Geerling G. Animal models of dry eye. Dev Ophthalmol. 2008;41:298-312. doi: 10.1159/000131097.

    PubMed 18453777

  • Chisari G, Chisari EM, Francaviglia A, Chisari CG. The mixture of bifidobacterium associated with fructo-oligosaccharides reduces the damage of the ocular surface. Clin Ter. 2017 May-Jun;168(3):e181-e185. doi: 10.7417/T.2017.2002.

    PubMed 28612893

Questions about this trial

What is this clinical trial studying?

A study testing Probiotics in people with Dry Eye, run by Chung Shan Medical University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Schirmer's Test Value from Baseline (time frame: on baseline and day36). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05906381, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.

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